Enzyme Preparations Used in Food (Partial List)

Food ingredients may be "food additives" that are approved by FDA for specific uses or GRAS (generally recognized as safe) substances. A substance may be GRAS only if its general recognition of safety is based on the views of experts qualified to evaluate the safety of the substance. GRAS status may be based either on a history of safe use in food prior to 1958 or on scientific procedures, which require the same quantity and quality of evidence as would be required to obtain a food additive regulation. Because GRAS status may be either affirmed by FDA or determined independently by qualified experts, FDA's regulations do not include all GRAS ingredients and the specific uses described in the GRAS regulations may not be comprehensive for the listed ingredients.

The following list, which derives partially from FDA's regulations in Title 21 of the Code of Federal Regulations (21 CFR), includes approved food additives and substances whose GRAS status has been affirmed by FDA. This list includes some ingredients that are not listed in 21 CFR but have been the subject of opinion letters from FDA to individuals who asked whether FDA would object to the use of the ingredient in food on the basis of an independent GRAS determination. In addition, enzyme preparations may be the subject of a GRAS notice. For further information, consult the GRAS Notice Inventory. Because the list below is not updated on a regular basis, questions about the regulatory status of enzyme preparations that are not on this list may be directed to us via electronic mail at premarkt@fda.hhs.gov.

The following is a compilation of enzymes listed as food additives in 21 CFR Part 173. Conditions for their use are prescribed in the referent regulations and are predicated on the use of good manufacturing practices.

α-galactosidase derived from Mortierella vinaceae var. raffinoseutilizer for use in the production of sucrose from sugar beets.

§173.150

Milk-clotting enzymes, microbial for use in the production of cheese (Milk-clotting enzymes are derived from Endothia parasitica Bacillus cereus, Mucor pusillus Lindt and Mucor miehei Cooney et Emerson and Aspergillus oryzae modified to contain the gene for aspartic proteinase from Rhizomucor miehei var Cooney et Emerson).

The following food standard lists a permitted enzyme preparation

Table 2. Enzyme preparation specified in a food standard

Section in 21 CFR

Description of Food

§137.105

Flour may contain α-amylase obtained from the fungus Aspergillus oryzae.

Please be aware that FDA has not affirmed as GRAS all food ingredients that it may consider GRAS. Therefore, the table below does not represent a complete list of all enzymes that FDA may view as GRAS for some uses.

The following is a compilation of enzymes that have been affirmed as GRAS by FDA for specified or unspecified food uses and listed in 21 CFR Part 184. Conditions for their use are prescribed in the referent regulations and are predicated on the use of nontoxicogenic strains of the respective organisms and on the use of current good manufacturing practice (184.1(b)).

Bromelain derived from pineapples, Ananas comosus and Ananas bracteatus used to hydrolyze proteins and polypeptides.

§184.1027

Mixed carbohydrase and protease enzyme product derived from Bacillus licheniformis for use in hydrolyzing proteins and carbohydrates in the preparation of alcoholic beverages, candy, nutritive sweeteners and protein hydrolysates.

§184.1034

Catalase from bovine liver used to decompose hydrogen peroxide

§184.1316

Ficin (peptide hydrolase) from the genus Ficus to hydrolyze proteins and polypeptides.

Trypsin (peptide hydrolase) from porcine or bovine pancreas used to hydrolyze proteins.

§184.1924

Urease enzyme preparation from Lactobacillus fermentum for use in the production of wine.

§184.1985

Aminopeptidase enzyme preparation from Lactococcus lactisused as an optional ingredient for flavor development in the manufacture of cheddar cheese.

The following is a compilation of microbially derived enzymes which the FDA recognized as GRAS in opinion letters issued in the early 1960's. The opinions are predicated on the use of nonpathogenic and nontoxicogenic strains of the respective organisms and on the use of current good manufacturing practice.